Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The rate of change in the total score of the Clinical Dementia Rating Scale
研究概览
简要总结
The goal of this clinical trial is to To demonstrate the Safety and Efficacy of dcLVA Surgery for the Treatment of Alzheimer's Disease. Patients who meet the inclusion and exclusion criteria and consent to participate will be randomly assigned to either the experimental group (receiving dcLVA surgery plus standard medication) or the control group (receiving standard medication alone)
Participants will:
Undergo cognitive assessment and brain MRI assessment; Undergo a lumbar puncture; Undergo an injection of 20ml of gadodiamide contrast agent at a concentration of 0.5 mmol/L (1ml gadodiamide: 20ml 0.9% saline).
Primary Outcome Measures: The change in the sum of Clinical Dementia Rating Scale (CDR) scores at 12-month in relative to baseline
详细描述
This study aims to enroll patients diagnosed with AD. Patients who meet the inclusion and exclusion criteria and consent to participate will be randomly assigned to either the experimental group (receiving dcLVA surgery plus standard medication) or the control group (receiving standard medication alone). Following randomization, patients will undergo cognitive and brain MRI assessments, a lumbar puncture, and an injection of 20ml of gadodiamide contrast agent at a concentration of 0.5 mmol/L (1ml gadodiamide: 20ml 0.9% saline). MRI imaging scans will be conducted at 4 hours, 24 hours, and 48 hours post-injection to measure the dural signal unit ratio, which will be used to assess glymphatic clearance function. The study will track changes in cognitive function and glymphatic clearance function at baseline and during follow-up periods (7 days post-surgery, 6 months, and 12 months) and will evaluate the safety of the two treatment approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as an AD patient according to biological markers and clinical symptoms;
- •Over 35 years old and with an MMSE or MOCA score ≤ 26;
- •The patient or family member has signed an informed consent form.
排除标准
- •Inability to cooperate with lumbar puncture;
- •Cognitive impairment due to neurological infections (e.g., HIV, neurosyphilis, autoimmune encephalitis) or systemic diseases (e.g., diabetes, thyroid dysfunction);
- •Significant organ dysfunction (heart, lung, liver, kidney);
- •Coagulation disorders or contraindications to surgery;
- •Inability to fully cooperate with follow-up visits.
研究组 & 干预措施
experimental group
receiving dcLVA surgery plus standard medication
干预措施: Deep Cervical lymphatlc-Venous Anastomosis Surgery (Procedure)
experimental group
receiving dcLVA surgery plus standard medication
干预措施: Lecanemab (Drug)
control group
receiving standard medication alone
干预措施: Lecanemab (Drug)
结局指标
主要结局
The rate of change in the total score of the Clinical Dementia Rating Scale
时间窗: Time Frame: baseline,7 days post-surgery,3-month,6-month and 12-month
The change in the sum of Clinical Dementia Rating Scale (CDR) scores at 12-month in relative to baseline , using the Chinese version of the CDR scale, with a score range of 0-3 points for each item.The total score ranges from a minimum of 0 points to a maximum of 18 points, where a higher score indicates a worse outcome.
次要结局
未报告次要终点